CBT for Insomnia in Breast Cancer Survivors

(COIN Trial)

Recruiting at 4 trial locations

Overseen By Katie Smith, BA

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Johns Hopkins University

Must not be taking: Sedative hypnotics

Disqualifiers: Bipolar, Psychotic, Seizure, Autoimmune, others

Compensation: Varies

Number of Visits: 30

250 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to assist women who have had early-stage breast cancer and face insomnia and weight issues. Researchers compare Cognitive-Behavioral Therapy for Insomnia (CBT-I) with basic sleep education to determine which is more effective when combined with a weight loss program. Women who have completed cancer treatment and experience sleep difficulties more than three nights a week might qualify. The goal is to discover if improving sleep can also aid in weight loss and enhance overall well-being. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could improve the quality of life for many women.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes those using medications that cause sleep disturbances or weight changes. It's best to discuss your specific medications with the trial team.

What prior data suggests that Cognitive-Behavioral Therapy for Insomnia (CBT-I) and Sleep Education Control (EDU) are safe for breast cancer survivors with insomnia?

Research has shown that Cognitive-Behavioral Therapy for Insomnia (CBT-I) is generally safe for breast cancer survivors who have trouble sleeping. Studies have found that CBT-I can improve sleep and reduce tiredness and depression in cancer survivors. Importantly, these studies did not report any serious side effects, indicating that the treatment is well-tolerated.

The therapy includes structured sessions that teach new sleep habits and how to change thoughts that might keep someone awake. Since it doesn't involve medication, it avoids the risks associated with drugs.

In this trial, researchers are comparing the CBT-I treatment to a sleep education control. Participants will receive either CBT-I or general sleep information. The sleep education control matches the timing and format of CBT-I sessions but does not include personalized behavioral changes.

Overall, evidence suggests that CBT-I is a safe option for treating insomnia in breast cancer survivors. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Cognitive-Behavioral Therapy for Insomnia (CBT-I) because it offers a targeted approach to improve sleep specifically for breast cancer survivors, who often face unique sleep challenges. Unlike general sleep medications, which can have side effects and don't address the root causes, CBT-I focuses on changing the thoughts and behaviors around sleep. This therapy is also distinct because it is delivered remotely, making it accessible for participants no matter where they live. The addition of maintenance sessions every other month helps reinforce positive sleep habits, aiming for long-term benefits.

What evidence suggests that this trial's treatments could be effective for insomnia in breast cancer survivors?

Research shows that Cognitive-Behavioral Therapy for Insomnia (CBT-I), which participants in this trial may receive, can help breast cancer survivors sleep better. Studies have found that CBT-I not only improves sleep but also reduces tiredness and stress. In one study, breast cancer survivors who used a voice-activated CBT-I program slept better. Additionally, online CBT-I with clinician support improved sleep and other symptoms for cancer survivors. Three years after receiving internet-based CBT-I, participants slept better and experienced less severe insomnia than before treatment. These findings suggest CBT-I can be a strong option for managing insomnia in this group. ^{1 2 6 7 8}

Who Is on the Research Team?

Janelle Wilder Coughlin, PHD

Principal Investigator

Johns Hopkins University

Michael Smith, PHD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for overweight or obese female breast cancer survivors, aged 18+, who have insomnia. They must be willing to lose weight and have completed cancer treatments at least 3 months prior. Exclusions include other sleep disorders (except mild apnea), drug abuse, current smokers, or those with unstable psychiatric conditions.

Inclusion Criteria

I was diagnosed with early-stage breast cancer or DCIS within the last 10 years.

You have trouble falling asleep or staying asleep for more than 30 minutes on most nights.

You have a score of 9 or more on a test that measures how bad your insomnia is.

Exclusion Criteria

I am not planning to join any sleep or weight loss programs and my sleep test shows moderate to severe issues.

I do not have any serious health or mental conditions that could interfere with treatment.

I have a sleep disorder other than insomnia, but if it's sleep apnea, it's under control with PAP therapy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 video visit

Sleep Intervention

Participants undergo a cognitive-behavioral intervention for insomnia (CBT-I) or a sleep education control (EDU) over 8 weeks

8 weeks

6 video sessions

Behavioral Weight Loss (BWL)

Participants engage in a behavioral weight loss program using social cognitive theory and motivational interviewing

12 months

19 video sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

4 in-person assessment visits

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive-Behavioral Therapy for Insomnia (CBT-I)
• Sleep Education Control (EDU)

Trial Overview The study tests if Cognitive-Behavioral Therapy for Insomnia (CBT-I) enhances the effectiveness of a subsequent behavioral weight loss program compared to just receiving sleep education followed by the same weight loss program in women who've had early stage breast cancer.

How Is the Trial Designed?

Group I: Cognitive-Behavioral Therapy for Insomnia (CBT-I) Experimental Treatment 1 Intervention

The proposed intervention consists of 6 remotely-delivered sessions; Weeks 1, 2, 4, 6, 7, and 8, with weeks 3 and 5 being "rest weeks". Session 1 will be 60-90 mins, Session 2 will be \~60 mins, and remaining visits are \~45 mins. The investigators propose a methodological innovation for CBT-I, which involves conducting 15-minute sessions every other month during the BWL intervention. Prior to these maintenance sessions, participants in the CBT-I+BWL group will complete electronic sleep diaries for one week and interventionists will use this information in sessions to sustain and enhance long-term outcomes by using MI to reinforce application of CBT-I session content.

Group II: Sleep Education Control (EDU) Placebo Group 1 Intervention

The EDU intervention will parallel the CBT-I intervention in number, format and length of all sessions, including maintenance sessions. It provides basic information about sleep and cancer, widely available to the public. EDU content does not include any individualized behavioral instructions, sleep diary monitoring during the intervention, or behavior change counseling. Content is presented didactically only.

Cognitive-Behavioral Therapy for Insomnia (CBT-I) is already approved in United States, European Union for the following indications:

Approved in United States as Cognitive-Behavioral Therapy for Insomnia for:

• Insomnia
• Chronic insomnia
• Sleep disturbances in cancer survivors

Approved in European Union as Cognitive-Behavioral Therapy for Insomnia for:

• Insomnia
• Chronic insomnia
• Sleep disturbances in cancer survivors

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Published Research Related to This Trial

Cognitive Behavioral Therapy for Insomnia (CBT-I) is an effective treatment for insomnia in breast cancer survivors, significantly improving sleep quality, mood, and overall quality of life based on a review of 16 studies.

The benefits of CBT-I, including reductions in fatigue and menopausal symptoms, are durable, lasting up to 12 months after treatment, highlighting its potential as a long-term solution for insomnia in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Behavioral Therapy for Insomnia in Breast Cancer Survivors: A Review of the Literature. Aricò, D., Raggi, A., Ferri, R.[2020]

Internet-delivered cognitive-behavioral therapy for insomnia (iCBT-I) significantly improved sleep outcomes in 255 breast cancer survivors with clinically significant sleep disturbances, showing a strong effect on insomnia severity (Cohen's d = 1.17).

The benefits of iCBT-I were not only immediate but also sustained at follow-up, indicating its potential as a low-cost and effective treatment option that could be integrated into cancer rehabilitation programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet-Delivered Cognitive-Behavioral Therapy for Insomnia in Breast Cancer Survivors: A Randomized Controlled Trial. Zachariae, R., Amidi, A., Damholdt, MF., et al.[2023]

A pilot study involving 30 Spanish-speaking breast cancer survivors showed that a 6-week eHealth Cognitive-Behavioral Therapy for Insomnia (CBT-I) intervention was highly acceptable and feasible, with excellent recruitment (95%) and retention (97%).

Post-treatment results indicated that CBT-I significantly improved insomnia symptoms, sleep disturbance, and sleep efficiency, with medium to large effect sizes, demonstrating its preliminary efficacy for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot randomized controlled trial of eHealth cognitive-behavioral therapy for insomnia among Spanish-speaking breast cancer survivors. Oswald, LB., Morales-Cruz, J., Eisel, SL., et al.[2023]

The Survivorship Sleep Program (SSP), a synchronous virtual cognitive behavioral therapy for insomnia (CBT-I) tailored for cancer survivors, demonstrated high feasibility and acceptability, with 90% retention and 100% attendance among participants.

The SSP led to significant reductions in insomnia severity compared to enhanced usual care, with a large effect size (Cohen d = 1.19) that was maintained at a 1-month follow-up, indicating its potential effectiveness for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Survivorship Sleep Program (SSP): A synchronous, virtual cognitive behavioral therapy for insomnia pilot program among cancer survivors. Hall, DL., Arditte Hall, KA., Gorman, MJ., et al.[2023]

In a pilot study involving 21 breast cancer survivors, individual cognitive behavioral therapy for insomnia (IND-CBT-I) significantly improved self-rated insomnia and sleep quality compared to a delayed treatment control group.

The results suggest that IND-CBT-I is a practical and effective option for improving sleep in breast cancer survivors, making it accessible in outpatient settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Individual cognitive behavioral therapy for insomnia in breast cancer survivors: a randomized controlled crossover pilot study. Fiorentino, L., McQuaid, JR., Liu, L., et al.[2021]

This study aims to evaluate the effectiveness of Brief Behavioral Therapy for Insomnia (BBTI) in reducing insomnia among 158 cancer survivors, marking the first time this approach is tested in such a diverse group.

The primary outcome will be assessed using the Insomnia Severity Index (ISI), with follow-up assessments planned at 1, 3, and 12 months to determine the durability of the intervention's effects on sleep quality and overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A nurse-delivered intervention to reduce insomnia in cancer survivors: Study protocol for a randomized-controlled trial. Kwon, M., Dickerson, SS., Wilding, GE., et al.[2023]

A pilot study involving 38 cancer survivors showed that a brief, group-based cognitive-behavioral therapy for insomnia (CBT-Insomnia) program significantly improved sleep efficiency, quality, and insomnia symptoms after just three sessions over one month.

Despite experiencing insomnia symptoms for an average of 2.4 years, many survivors had not discussed their sleep issues with healthcare providers, highlighting the need for increased awareness and access to insomnia treatments in oncology settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot trial of brief group cognitive-behavioral treatment for insomnia in an adult cancer survivorship program. Zhou, ES., Partridge, AH., Recklitis, CJ.[2022]

The Sleep Treatment Education Program-1 (STEP-1) significantly reduced insomnia symptoms in cancer survivors, with mean Insomnia Severity Index scores dropping from 15.73 at baseline to 9.73 at one-month follow-up, indicating its potential efficacy as a treatment.

STEP-1 can be effectively delivered via videoconference, making it a more accessible option for cancer survivors who may face barriers to traditional therapy, thus improving their chances of receiving necessary insomnia care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the Sleep Treatment Education Program (STEP-1): A single-session educational workshop addressing insomnia in cancer survivors. Chevalier, LL., Fine, E., Sharma, A., et al.[2023]

Cognitive Behavioral Therapy for Insomnia (CBT-I) has been shown to significantly improve sleep quality and psychological outcomes in cancer patients and survivors, based on a review of 12 studies.

CBT-I not only enhances sleep but may also positively affect mood, fatigue, and overall quality of life, and it can be delivered through various methods to reach more patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleeping well with cancer: a systematic review of cognitive behavioral therapy for insomnia in cancer patients. Garland, SN., Johnson, JA., Savard, J., et al.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/29471478/

Internet-Delivered Cognitive-Behavioral Therapy for ... iCBT-I appears to be effective in breast cancer survivors, with additional benefit in terms of reduced fatigue.

2. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2823907

Voice-Activated Cognitive Behavioral Therapy for Insomnia This randomized clinical trial of an in-home, voice-activated CBT-I program among breast cancer survivors found that the intervention improved insomnia ...

3. frontiersin.org frontiersin.org/journals/psychology/articles/10.3389/fpsyg.2016.01162/full

Cognitive Behavioral Therapy for Insomnia in Breast ... Overall, results have been quite consistent in showing that CBT-I is associated not only with improved sleep but also with a reduction of psychological distress ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1389945725000723

Web-based cognitive-behavioral therapy for insomnia in ... Web-based CBT-I with clinician support appears to be an effective treatment for insomnia in cancer survivors, offering meaningful benefits for comorbid symptoms ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1389945722001563

Changes in sleep following internet-delivered cognitive ... Three years after internet-based CBT-I, sleep quality and insomnia severity were significantly lower than pre-treatment levels.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05813392

Digital Cognitive Behavioral Therapy for Insomnia ... To explore the efficacy of dCBT-I therapy for chronic insomnia among breast cancer survivors in China, we propose to conduct a randomized, parallel controlled ...

7. academic.oup.com academic.oup.com/sleep/article/48/6/zsaf014/7960093

Impact and mechanisms of cognitive behavioral therapy for ... CBT-I resulted in significant improvement in fatigue, and these effects were largely accounted for by changes in insomnia.

8. jcsm.aasm.org jcsm.aasm.org/doi/10.5664/jcsm.7586

Cognitive Behavioral Therapy for Insomnia Reduces ... This study shows that in cancer survivors with insomnia, CBT-I has the potential to improve not only insomnia, but also comorbid depression through ...